Kornimate/medical-research-clean huggingface dataset:
pilot study evaluate efficacy of grazoprevir + elbasvir for 12 or 16 weeks in liver transplant recipients.

Conditions: Liver Transplantation; Hepatitis C

Summary: pilot, single center, open-label study to evaluate the efficacy and tolerability of grazoprevir and elbasvir in hcv gt1 and 4 liver transplant recipients.30 liver transplant recipients with hepatitis c recurrence.


Eligibility criteria:
inclusion criteria: * age between 18 and 78 year-old. * previous liver transplantation(more than 6 month). * genotype 1 and 4 infection. * hepatitis c recurrence defined by the presence of abnormal liver function test, positive hcv-rna, histological signs of hepatitis c recurrence. * viral load ≥10000ui/ml. * immunosuppression with tacrolimus and/or mycophenolate (prednisone use is allowed at low dose, ≤10 mg/d). * treatment naïve or treatment experienced (peg-rbv or triple therapy). exclusion criteria: * genotype 2, 3, 5 or 6 infection. * decompensated cirrhosis defined by the presence of actual or previous history of clinical decompensation including ascites, hepatic encephalopathy, variceal bleeding or spontaneous bacterial peritonitis, or a child-pugh b or c. * hepatocellular carcinoma after liver transplantation. * total bilirubin \> 3 mg/dl. * immunosuppression with cyclosporine or an mtor inhibitor (everolimus or sirolimus). * severe extrahepatic diseases: cardiovascular, respiratory, cerebrovascular and poorly controlled diabetes. * platelets \< 75 x 109 cells/l. * neutrophil count \< 0.5 x 109 cells/l. * hemoglobin \< 9 g/dl. * albumin \< 3g/dl. * hiv infection. * hepatitis b infection. * active intake of toxic amounts of alcohol or recreational drugs. * females who are pregnant, become to be pregnant or breastfeeding or males whose partners are pregnant, become to be pregnant or breastfeeding. * intake of disallowed medications including(but not limited to): 1. antibiotics: clarithromycin, erythromycin, telithromycin, nafcillin, rifampin 2. antifungals: itraconazole, ketoconazole, voriconazole 3. antihypertensives: nifedipine 4. anticonvulsants: carbamazepine, phenytoin, phenobarbital 5. bosentan 6. modafinil 7. st.jonh's wort 8. immunosuppressants: cyclosporin, everolimus, sirolimus 9. diabetes agents: glibenclamide, glyburide 10. lipid lowering agents: gemfibrozil 11. eltrombopag 12. lapatinib 13. hiv medications: efavirenz, etravirine, all ritonavir boosted and unboosted hiv protease inhibitors 14. statins: simvastatin, fluvastatin, rosuvastatin at doses greater than 10 mg/d, atorvastatin at doses greater than 10 mg/d.
cp-690,550 pharmacokinetics in healthy chinese subjects

Conditions: Healthy

Summary: this study is designed to evaluate the levels of cp-690,550 in the blood of healthy chinese subjects following both single doses and multiple doses of drug.


Eligibility criteria:
inclusion criteria: * healthy chinese volunteers * no evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis (tb) exclusion criteria: * clinically significant infections within the past 3 months * positive screening test for hepatitis b surface antigen, anti-hepatitis c antibody, or human immunodeficiency virus * pregnant or nursing women

Keywords: rheumatoid arthritis
clinical significance of community-acquired respiratory virus infection and longitudinal analysis of the lung microbiome in lung transplantation

Conditions: Lung Transplant Infection; Lung Transplant Rejection

Summary: the purpose of this study is to evaluate the clinical significance of community-acquired respiratory virus (carv) infection in patients with lung transplantation;explore the lung microbiome dynamics within one year after lung transplantation;find the relationship between lung microbiome and chronic lung allograft dysfunction(clad).

title:clinical significance of community-acquired respiratory virus infection and longitudinal analysis of the lung microbiome in lung transplantation. background:infection affects the short-term prognosis of patients with lung transplantation and chronic lung allograft dysfunction(clad) limits their long-term survival.it is important to provide more theoretical support for early diagnosis and treatment of acute respiratory tract infection and clad in patients with lung transplantation. study objectives:evaluate the clinical significance of community-acquired respiratory virus (carv) infection in patients with lung transplantation;explore the lung microbiome dynamics within one year after lung transplantation;find the relationship between lung microbiome and clad. study design:a prospective and longitudinal study,following up the patients for 3 years. sample size:100 cases. study methods:carv detection for respiratory specimens are performed during acute infection and routine re-testing in patients after lung transplantation,following up the patients who have positive findings to analyze the progression rates to lower respiratory tract infection,mortality rate within 90 days and risk factors associated with progression and death.for hrv/covs/hbov detecting positive patients, consecutively collect respiratory specimens to quantitate viral load and combine virus serology to further confirm their pathogenicity on host.complete a longitudinal 16s ribosomal rna and metagenomics survey of the lung microbiome on respiratory samples collected from routine testing or re-testing（pre-operation,24 hours after the operation，day 3, day 7, week 2, week 3, month 1, month 3, month 6, month 9, month 12 , month 18, month 24, month 30, month 36) to explore the lung microbiome dynamics within one year after lung transplantation and find the relationship between lung microbiome and clad after 3 years follow-up.besides,collect the peripheral blood of some patients for transcriptome and/or whole genome sequencing to screen for the host susceptibility genes.

Eligibility criteria:
inclusion criteria: * 1.patients with lung transplantation. 2.the patients who agree to participate in this study and sign informed consent. exclusion criteria: -

Keywords: respiratory viral infections chronic lung allograft dysfunction lung microbiome
occlusion and disocclusion time in immediately loaded overdentures supported by two splinted versus non splinted interforaminal implants

Conditions: Edentulous Jaw

Summary: complete denture wearers struggle to eat well with their dentures due to poor denture retention, stability, and occlusal disharmony. so, the current study protocol aims to compare the occlusion/ disocclusion time in immediately loaded implant retained overdentures supported by two interforaminal implants; splinted versus non splinted dental implants compared to the conventional complete denture.

the gold standard treatment for completely edentulous patients is a removable complete denture, which satisfies patients functional and aesthetic requirements at a low cost. however, the main problem associated with a complete denture is the instability of the complete removable denture, especially the mandibular one. implant-assisted overdentures over two or three implants are used as a treatment option to increase stability, function, and retention of the denture at a reasonable cost. the immediate loading protocol allows the placement of temporary restoration on the day of implant placement surgery. pierluigi mondani pioneered intraoral welding in the early 1970s as an approach to load patients immediately with resin prosthesis and weld titanium implants to a titanium bar in their mouths. the technique of intraoral welding provides rigid splinting in cases of immediate implant loading. occlusal loads and stability of occlusion are important to consider in the immediate loading of implants to avoid implant biomechanical failures, marginal bone loss, or even complete loss of osseointegration. quantitative analyzers like t-scans, which are pressure-sensitive films, and virtual technology give a precise method of assessing the sequence of time and occlusal contact force magnitude by converting qualitative data into quantitative parameters. so, the current study protocol aims to compare the occlusion/ disocclusion time in immediately loaded implant retained overdentures supported by two interforaminal implants; splinted versus non splinted dental implants compared to the conventional complete denture.

Eligibility criteria:
inclusion criteria: * completely edentulous patients * non-smokers * good oral hygiene * motivated patients exclusion criteria: * major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus * the need for extensive bone grafting in planned implant site * pregnancy * patients under bisphosphonate treatment * limited mouth-opening for executing the implant surgery.
predicting epileptogenic tubers in patients with tuberous sclerosis complex

Conditions: Tuberous Sclerosis Complex

Summary: accurate localization of epileptogenic tubers (ets) in patients with tuberous sclerosis complex (tsc) is essential but challenging because ets lack distinct pathological or genetic markers that differentiate them from other cortical tubers. approximately 60% of patients fail to have their ets identified through noninvasive preoperative evaluations, highlighting the clinical need for an efficient, noninvasive et localization method. using mri data from training datasets, we developed a novel noninvasive fusion model that combines a risk model based on lesion network mapping with a prediction model using brain functional connectivity and random forest algorithms. a retrospective analysis was conducted on tsc patients with epilepsy who underwent resective surgery. tubers were classified as true-ets, false-ets, or true non-ets based on resection locations and postoperative seizure-freedom. the model calculated and ranked the et probability for each tuber for every patient, and its accuracy was assessed based on postoperative seizure outcomes.


Eligibility criteria:
inclusion criteria: (1) male or female patients aged ≥6 months; (2) patients meeting the diagnostic criteria for tsc according to northrup's guidelines;17 (3) patients in whom the clinical evaluation determined that a single surgical target, or hypothesized primary ez, was identified by a multidisciplinary specialist team at epilepsy centers of beijing children's hospital, pla general hospital, or shenzhen children's hospital in china; (4) patients who underwent resective surgery between july 2016 and june 2023, with a 1-year follow-up completed by june 2024; and (5) availability of patients with available preoperative and postoperative mri t2-flair imaging. exclusion criteria: * (1) patients with a history of craniotomy, serious head injury, neuromodulation therapy, or corpus callosotomy before or within one year after the resective surgery; and (2) subjects lacking key clinical or mri data. this study was approved by the ethics commission of beijing children's hospital.

Keywords: tsc tsc mri
a study to learn about recifercept in patients with achondroplasia

Conditions: Achondroplasia

Summary: the purpose of this study is to learn about the study medicine (called recifercept) in people with achondroplasia. achondroplasia is a very rare disease and patients of achondroplasia have short arms and legs. the study will include data already collected from a recifercept clinical trial and data collected from a separate study of achondroplasia. this study will compare patient experiences and will help the investigators determine if the study medicine, recifercept, is effective.


Eligibility criteria:
inclusion criteria: * all patients from study c4181005 who have completed visits 1 through 11 (at d183) will be included in this project. to construct a concurrent external control, patients from study c4181001 will need to meet the following inclusion criteria from study c4181005 to be eligible for inclusion: * documented, confirmed genetic diagnosis of achondroplasia from historical medical records (test must have been performed at a laboratory fully accredited for genetic testing under local regulations) * aged ≥ 3 months to \<11 years (up to the day before 11th birthday inclusive) at time of enrollment into the observational natural history study. * havecompleted at least 2 valid height/length measurements (at least 3 months apart) * assessed for tanner stage 1 during physical examination before or at enrollment (must include assessment of breast development for females, testicular stage for males) * able to stand independently for height measurements (if ≥ 2 years of age at enrollment); if aged \<2 years at enrollment, has a documented historical mri brain/cervical spine performed in the previous 12 months. * have at least 6 months of available follow-up data after enrollment into the natural history study exclusion criteria: * patients meeting any of the following criteria will not be included in the study: * presence of severe obesity (bmi\>95% percentile on hoover-fong bmi charts); * body weight \ 30kg * history of chronic kidney disease (ckd) or renal impairment * history of receipt of any treatment that are known to potentially affect growth (including oral steroids \> 5 days in the last 6 months before enrollment, high dose inhaled corticosteroids (\>800 mcg/day beclametasone equivalent) and medication for attention deficient hyperactivity disorder. * less than 6 months since fracture or surgical procedure of any bone determined from the baseline visit date. * presence of any internal guided growth plates/devices * history of removal of internal guided growth plates/devices within 6 months prior to enrollment
lignocaine versus sodium bicarbonate on reducing pain during propofol injection

Conditions: Propofol Adverse Reaction

Summary: to compare the effect of adding lignocaine and sodium bicarbonate to propofol in reducing pain on propofol injection (popi).

propofol is the most commonly used intravenous (iv) anesthetic drug for induction of anesthesia and for sedation. it is almost an ideal iv anesthetic agent, but pain which occur during its injection still remains a problem. this pain may not be a serious complication, but most patients remember it as an unpleasant encounter with anesthetists. in one survey, pain on propofol injection (popi) stands 7th most important problem in the current practice of anesthesia . about 70 to 90% of patients who were given propofol for anesthesia induction experience pain during injection and this pain can be quite severe. all phenols irritate skin and mucous membranes. thus, propofol being an alkyl-phenol is expected to induce pain despite the fact that it is almost isotonic. popi has also been described as angialgia which means that the pain is due to vascular involvement . popi is immediate as well as delayed after 10-20 seconds . the immediate pain is due to irritation of vein endothelium while as delayed pain is due to the release of mediators such a kininogen from kinin cascade . the most frequently used drug to alleviate popi is intravenous lignocaine. the use of lignocaine to decrease popi is due to its local anesthetic effect on the veins. however, it does not alleviate pain effectively in about 40% of the patients treated in this way (2). administration of sodium bicarbonate was proved to reduce popi. the proposed mechanism is through increasing sodium ions concentration as well as increasing serum ph through its buffering effect.

Eligibility criteria:
inclusion criteria: * patients aged 18 to 65 years old. * patients classified as asa i or ii. exclusion criteria: * patients with the history of allergy to propofol or lignocaine. * patients took any medication for analgesia or sedation in the past 24 hours. * body mass index (bmi) more than 30. * patients classified as asa iii \& iv. * severe mental illness.

Keywords: lignocaine,sodium bicarbonate,pain on propofol injection
ar08 for treatment of adhd in children

Conditions: ADHD

Summary: this is a multicenter, multiple dose, randomized, double-blind, placebo-controlled, forced titration study. patients will be randomized to 1 of 4 treatment groups in a 1:1:1:1 ratio. one-hundred twenty (120) patients are planned to be randomized. each patient will receive ar08 (0.5, 1, or 2 mg per day) or matching placebo for seven (7) weeks.


Eligibility criteria:
inclusion criteria: 1. meets dsm-iv-tr criteria for a primary diagnosis of adhd based on structured clinical interview, mini-kid, as assessed by the investigator 2. minimum score of 28 on the adhd-rs-iv at baseline 3. male or female ages 6 - 17 years, inclusive, at the time of screening 4. weighs ≥21 kg (46 pounds). 5. is functioning at age appropriate levels intellectually, as deemed by the investigator. exclusion criteria: 1. has a comorbid psychiatric diagnosis (comorbid psychiatric diagnosis will be established by the mini-kid interview). 2. has a positive response to either question 4 or 5 of the baseline /screening version of the pediatric columbia suicide severity rating scale (c-ssrs) 3. history of daily usage (at least 28 days/month) of either anti-hypertensive or prophylactic anti-migraine medications prior to screening 4. current usage of medications known to cause qtc prolongation or adhd medications.

Keywords: adhd ar08 adrenergic receptor agonists randomized, placebo-controlled clinical trial
coronary artery disease and renal failure registry

Conditions: Coronary Artery Disease; Renal Failure

Summary: it is the aim of the multi-centric and prospective registry to analyze in patients with cad the impact of different grades of renal failure on the outcome and course of the patients and to correlate these with clinical variables. in particular, the registry has the following objectives: * prospective consecutive assessment of all patients with coronary artery disease and renal failure in the participating hospitals of the registry * evaluation of the outcome and course of patients with regard to their different stages of renal failure at baseline * analysis of the impact of different therapeutic strategies on acute and long-term outcomes * identification of clinical risk factors, novel biomarkers and genetic markers for an unfavorable long-term outcome


Eligibility criteria:
inclusion criteria: * women and men \>= 18 years of age * patients with actually performed interventional coronary angiography and there a documented coronary heart disease, defined as at least one documented stenosis \>= 50 % in at least one main coronary vessel (main steam; rcx; riva; rca) * european/caucasian descent (european/caucasian parents and grandparents) * availability of an urine, serum- and edta blood sample of the patient * documented consent of patients for handling of personal medical data, including a genetic analysis exclusion criteria: * patients who have been already recruited into this registry * patients with organ transplantations, apart from kidney transplantations * immunosuppressive therapy, apart from immunosuppressive therapy after kidney transplantation * patients with polycystic renal disease * pregnant and breastfeeding patients * known malignant tumor
assessment of diastolic function during the transitional period and infancy using serial echocardiography

Conditions: Diastolic Dysfunction; Neonatal Encephalopathy; Small for Gestational Age at Delivery; Transient Tachypnea of the Newborn; Trisomy 21; Gestational Diabetes

Summary: the goal of this single-centre longitudinal observational study is to create reference values for diastolic function parameters in neonates born at 35 weeks' gestation or above, and to assess the influence of pre-defined antenatal, intrapartum, maternal, and neonatal factors on cardiac function. the main question it aims to answer are: * what are the normal reference ranges for parameters of diastolic cardiac function in neonates? * how are these influenced by maternal, intrapartum and neonatal factors? * do the diastolic changes noted during the first two days of life persist into infancy? participants will have four echocardiographic assessments in total: * two during the first 48 hours of life (prior to discharge home) * two during infancy (as an outpatient)

participants will have their first echo to assess diastolic function, using both conventional and novel echocardiographic measure, within the first 6 to 18 hours of life approximately (day 1 scan) and this will be repeated at 30 to 42 hours of life (day 2 scan). both scans will involve a comprehensive structural assessment to confirm normal anatomy. all participants will be invited to return for follow-up targeted echocardiography assessments to evaluate function at approximately 6 - 9 months (scan 3) and at approximately 12 - 18 months of life (scan 4). at each of these visits, their weight, height, any interim hospital admissions, serious illnesses or medical issues and medications will be documented using a structured checklist format.

Eligibility criteria:
inclusion criteria: * birth at 35 weeks gestation or above * informed consent obtained exclusion criteria: * any apparent congenital anomalies * any known chromosomal abnormalities (except trisomy 21) * any known congenital structural heart disease (except patent ductus arteriosus, atrial septal defect, patent foramen ovale or ventricular septal defect)

Keywords: diastolic function neonatal transition longitudinal tissue doppler imaging speckle tracking echocardiography
investigating the impact of the sglt2 inhibitor empagliflozin on postprandial hypoglycaemia after gastric bypass

Conditions: Dumping Syndrome; Hypoglycemia, Reactive

Summary: bariatric surgery is an effective anti-obesity treatment providing durable weight loss and profound beneficial effects on glucose metabolism. however, bariatric surgery also comes with an increased risk for a late metabolic complication known as postbariatric hypoglycaemia (pbh). the condition presents with hypoglycaemic episodes 1-3 hours after meals and develops one to several years after bariatric surgery, mainly gastric bypass. pbh affects approximately 30% of patients without preexisting diabetes. for a subset of patients, hypoglycaemia-associated impairment of daily living and social functioning are commonly observed. the underlying mechanisms of pbh are multifactorial. it is considered that inadequately high insulin secretion caused by both accelerated glucose absorption from the gut and increased insulinotropic hormones such as glp-1 are important pathophysiologic mechanisms. empagliflozin, a sodium-glucose cotransporter 2 (sglt2) inhibitor reduces glucose exposure by increasing urinary glucose excretion. in a pilot study, a single dose of 10mg of empagliflozin taken before a mixed meal reduced the risk of pbh by 74%. both, postprandial glucose and insulin exposure were significantly lower with empagliflozin vs. placebo, which makes empagliflozin a potential treatment for pbh. in this study, treatment naïve patients will be randomized to receive either oral empagliflozin 25 mg daily in the morning for 20 days, followed by 2-6 weeks wash out and 20 days placebo once daily in the morning, or the reverse sequence. urine and blood analysis will be performed as detailed in the protocol.


Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * age 18 years or older * gastric bypass surgery ≥1 year ago * biochemically confirmed postprandial hypoglycaemia (plasma or sensor glucose \<3.0mmol/l) within the past three months exclusion criteria: * diabetes on anti-diabetic treatment (insulin and/or non-insulin agents) * genito-urinary infection, if not treated successfully * chronic kidney disease (defined as ckd-epi egfr \< 60 ml/min per 1.73 m2 body surface area) * pregnant and lactating women (urine pregnancy test to be performed for women of childbearing potential \[defined as women who are not surgically sterilized/ hysterectomized, and/ or who are postmenopausal for less than 12 months\]) or women of childbearing potential that refuse to use an effective contraceptive method \[birth control pill or intrauterine device (iud)\]). * inability to understand and follow the protocol * known allergy to the study drug * participation in another interventional clinical trial overlapping with the current trial